The Impact of a Prostaglandin’s First-Line Approval

Glaucoma subspecialists comment on how XALATAN’s FDA approval as a first-line treatment affects clinical practice.

BY ROBERT J. NOECKER, MD; PHILIP P. CHEN, MD; ROBERT D. FECHTNER, MD; AND EVE J. HIGGINBOTHAM, MD

In December 2002, the FDA approved latanoprost (XALATAN; Pharmacia Corporation, Peapack, NJ) as an initial treatment for elevated IOP associated with open-angle glaucoma or ocular hypertension. Currently, latanoprost is the only prostaglandin with this approval in the US. Glaucoma Today asked four glaucoma subspecialists how they thought FDA approval would affect clinical practice in this country.

ROBERT J. NOECKER, MD
The FDA’s recent approval of XALATAN as a first-line agent affirms what many glaucoma specialists and other ophthalmologists have been doing for a long time. This drug’s position as the most prescribed glaucoma medication shows that ophthalmologists rely on it. In fact, latanoprost and the similar drugs travaprost and bimatoprost now compose the largest class of ocular hypotensive agents. This position is a dramatic difference from 6 years ago when latanoprost first came to market in the US and beta-blockers were dominant.

Ophthalmologists have long been comfortable using many agents for off-label or nonindicated uses. It took little time for them to recognize that latanoprost was safer and usually more effective than timolol, the old standard for IOP reduction. As a result, they began acting in patients’ best interest, even though using a prostaglandin as first-line treatment was not consistent with the FDA labeling. XALATAN’s first-line approval from the FDA should reinforce clinicians’ shift to safer, more efficacious, and easier-to-use agents such as latanoprost and bimatoprost. This trend should continue into the future.

PHILIP P. CHEN, MD
From a practical standpoint, I am not sure how big an impact this approval will have, because many ophthalmologists have been prescribing prostaglandins off-label as first-line treatment. FDA approval may have an effect if some HMOs or other managed-care organizations have not allowed these drugs to be prescribed unless a patient has tried a beta-blocker or other approved agent first. The FDA’s decision will have little bearing on my own practice pattern. I have used prostaglandins as first-line treatment in some cases, but, for so many of my patients, the cost of medications is a consideration. I usually start with beta-blockers unless they are contraindicated, because these agents can be very effective, are generally well tolerated, and are available in a generic form, rendering them inexpensive.

ROBERT D. FETCHNER, MD
I do not need the FDA to tell me how to practice, and I don’t think they want to! I have been using drugs off-label for my entire career in glaucoma. I have used 5-fluorouracil and mitomycin C to improve the rate of success in glaucoma surgery, I have prescribed topical IOP-lowering drugs with less frequent dosing than the label indicates, and I have started patients on latanoprost as initial monotherapy. Nevertheless, I believe that the approval of latanoprost as first-line therapy is significant.

When the prostaglandin drugs were introduced, we knew nothing of their long-term safety and efficacy. They appeared to be at least as effective as topical beta-blockers and seemed likely to have less potential for causing systemic adverse effects, but they had unknown long-term ocular side effects. The FDA’s approval of latanoprost as first-line therapy signals that the long-term safety and efficacy data for latanoprost have been collected by the manufacturer and analyzed by the governmental agency charged with the responsibility to safeguard our patients.

Most ophthalmologists have probably used latanoprost off-label as initial monotherapy, but they can now do so with greater confidence that there will be no unpleasant surprises. I believe we will see an increased use of latanoprost as initial monotherapy for glaucoma and ocular hypertension. I also suspect that ophthalmologists will increase their use of other prostaglandins as first-line therapy as well, despite the fact that the long-term safety and efficacy data on these agents are not yet available and have not been reviewed by the FDA. Only time will tell if all prostaglandins are alike.

EVE J. HIGGINBOTHAM, MD
Latanoprost as a first-line drug is great news! Practically speaking, however, this announcement does not significantly change my practice pattern. For the last 3 years at least, I have been prescribing a prostaglandin analogue as a first-line drug for the majority of my patients. Why? The systemic side effects are certainly less with these agents, and the ease of administration and efficacy of this category of medication are additional important features.

Nonetheless, I have experienced occasional hurdles that should be easier to overcome with this most recent announcement. Third-party payors have often required additional paperwork to justify the use of a drug such as latanoprost versus a beta-blocker, which is cheaper. More commonly, a patient has been told that he or she would have to pay out-of-pocket. First-line approval makes me hopeful that I may more easily prescribe latanoprost without the additional phone calls and forms.

Additionally, the agent’s new status provides a greater level of comfort for both physician and patient. Certainly, I will continue to review the potential side effects. With the added feature of first-line status, however, I can reassure my patients that the drug is safe. It is also important to note the significant body of literature that reaffirms the safety of latanoprost and contributed to the drug’s new status.

First-line approval is excellent news for our patients. Regardless of our general practice pattern as physicians, the FDA’s seal of approval is critical.

Philip P. Chen, MD, is Associate Professor for the Department of Ophthalmology at the University of Washington in Seattle, as well as Chief of Ophthalmology and Residency Program Director at the University of Washington Medical Center. He holds no financial interest in the product mentioned herein. Dr. Chen may be reached at (206) 685-1969; pchen@u.washington.edu.

Robert D. Fechtner, MD, is Professor of Ophthalmology and Director of the Glaucoma Division at UMDNJ–New Jersey Medical School. He has received research support and served as a consultant to Pharmacia Corporation. Dr. Fechtner may be reached at (973) 972-2030; fechtner@umdnj.edu.

Eve J. Higginbotham, MD, is Professor and Chair of the Department of Ophthalmology at the University of Maryland School of Medicine in Baltimore. She has received grant support from Pharmacia Corporation and Allergan, Inc., and has been a speaker for both companies as well. Dr. Higginbotham may be reached at (410) 328-5929; fcwejh6786@aol.com.

Robert J. Noecker, MD, is Associate Professor of Ophthalmology and Director of the Glaucoma Service, Residency Program, and Clinical Studies Program at the University of Arizona in Tucson, Arizona. He holds no financial interest in the product mentioned herein but does receive research funding from Pharmacia Corporation and Allergan, Inc. Dr. Noecker may be reached at (520) 321-3677; rnoecker@eyes.arizona.edu.